BEUDAMED
    FDA Enforcement Class II Terminated

    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

    Recall: Z-0135-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0135-2017
    Event ID
    74774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    June 27, 2016
    Classification Date
    October 18, 2016
    Termination Date
    June 7, 2018
    Address
    525 French Rd, N/A, Utica, NY, 13502-5945, United States

    Description

    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

    Reason

    The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

    Code Info

    Beginning Lot Code 110609X to Ending Lot Code 20160308X

    Distribution

    Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

    Quantity

    N/A